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A technology of finasteride and xiongan, applied in the field of finasteride tablets and their preparation, can solve the problems of bad tablets, reduce product quality, etc., and achieve the effects of simple preparation method, improved quality, and accelerated dissolution
Pending Publication Date: 2022-01-04
HUNAN BAICAO PHARMA
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Problems solved by technology
Although the above-mentioned patents can improve the dissolution rate of finasteride tablets, none of them involve the hardness of finasteride tablets, which directly affects the coating and other processes in the preparation process, and the hardness is relatively high. It is also very easy to appear rotten chips in the process of preparation and transportation, which reduces the quality of the product
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Embodiment 1
[0026] A finasteride tablet, the prescription of which includes the following components: finasteride, lactose, low-substituted hydroxypropyl cellulose, pregelatinized starch, sodium carboxymethyl starch, magnesium stearate, hypromellose Sodium, 95% ethanol. The content of each component in the prescription is finasteride 1kg, lactose 18.0kg, low-substituted hydroxypropyl cellulose 3.0kg, pregelatinized starch 4.0kg, carboxymethyl starch sodium 2.0kg, magnesium stearate 0.3 kg, hypromellose 0.2kg, 95% ethanol 1.7kg, a total of 200,000 tablets were produced.
Embodiment 2
[0028] A preparation method of finasteride tablets, comprising the following steps:
[0029] 1) Weigh raw materials: Weigh 1 kg of finasteride, 18.0 kg of lactose, 3.0 kg of low-substituted hydroxypropyl cellulose, 4.0 kg of pregelatinized starch, 2.0 kg of sodium carboxymethyl starch, and 0.3 kg of magnesium stearate kg, hypromellose 0.2kg, 95% ethanol 1.7kg, and the weighed low-substituted hydroxypropyl cellulose is divided into 3 equal parts for subsequent use;
[0030] 2) Prepare adhesive: add 95% ethanol and water to prepare 20% ethanol solution, then dissolve hypromellose in 20% ethanol solution, and the obtained 20% hypromellose is the adhesive agent;
[0031] 3) Making soft materials: put 1 part of finasteride, lactose, pregelatinized starch, sodium carboxymethyl starch and low-substituted hydroxypropyl cellulose into a wet mixing granulator for 12 minutes to make it Mix evenly, add binder, and make qualified soft material;
[0032] 4) Wet granules: Take the prepare...
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Abstract
The invention discloses a finasteride tablet and a preparation method thereof. A prescription of the finasteride tablet comprises the following components by weight: 1kg of finasteride, 18.0 kg of lactose, 3.0 kg of low-substituted hydroxy propyl cellulose, 4.0 kg of pregelatinized starch, 2.0 kg of carboxymethyl starch sodium, 0.3 kg of magnesium stearate, 0.2 kg of hydroxypropyl methylcellulose and 1.7 kg of 95% ethanol, which are made into 200,000 tablets in total. The preparation method comprises the following steps: 1) weighing the raw materials; 2) preparing an adhesive: adding water into the 95% ethanol to prepare a 20% ethanol solution, and dissolving the hydroxypropyl methylcellulose in the 20% ethanol solution to obtain the adhesive; 3) preparing a soft material; 4) preparing wet granules; 5) performing drying; 6) performing granulation; 7) performing total mixing; 8) performing tableting; 9) performing coating; and 10) performing packing. The preparation method is simple, the hardness and the dissolution rate of the finasteride tablet can be increased by adding the low-substituted hydroxy propyl cellulose and the hydroxypropyl methylcellulose in the prescription, the subsequent coating operation is facilitated, the phenomenon of tablet breaking in the preparation process and the transportation process is effectively avoided, and the product quality is improved.
Description
technical field [0001] The invention relates to the technical field of medicine preparation, in particular to a finasteride tablet and a preparation method thereof. Background technique [0002] The main raw material of finasteride tablets is finasteride, which is a western medicine routinely used to treat benign prostatic hyperplasia. The conversion of testosterone in the prostate to dihydrotestosterone is the cause of benign prostatic hyperplasia or benign prostatic hypertrophy. Finasteride is a 4-aza steroid compound with the molecular formula C 23 h 36 N 2 o 2 , the molecular weight is 327.55, the chemical name is 17β-(N-tert-butylcarbamoyl)-4-aza-5α-androst-1-en-3-one, which is the process of testosterone metabolic conversion into dihydrotestosterone The specific inhibitor of the intracellular enzyme-type II 5a-reductase can inhibit the conversion of testosterone into dihydrotestosterone (DHT), and then effectively reduce the dihydrotestosterone in the blood and pro...
Claims
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Application Information
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